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Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome (PRADOTIM)

T

Toulouse University Hospital

Status and phase

Completed
Phase 3
Phase 2

Conditions

Prader-Willi Syndrome

Treatments

Drug: Oxytocin
Drug: Placebo
Drug: Placebo continuous
Drug: Oxytocin (OXT) continuous

Study type

Interventional

Funder types

Other

Identifiers

NCT02804373
13 6872 03

Details and patient eligibility

About

The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.

Enrollment

50 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Prader-Willi syndrome genetically confirmed
  • Absence of extension of the QT interval in the electrocardiogram
  • Absence of hypokalemia

Exclusion criteria

  • Psychiatric troubles
  • Anomalies of the heart rhythm in significant ECG
  • Hepatic insufficiency
  • Renal insufficiency
  • Patients presenting a pregnancy or breast-feeding
  • High sensibility to OT
  • High sensibility to the excipients of the product
  • Patients having family history of genetic pathology causing an extension of the interval QT
  • Patients having risk factors of advanced twist

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 3 patient groups, including a placebo group

placebo daily
Placebo Comparator group
Description:
daily administration of placebo during 28 days : placebo continuous
Treatment:
Drug: Placebo continuous
24 IU of oxytocin daily
Active Comparator group
Description:
24 IU of daily oxytocin administration during 28 days : oxytocin continuous
Treatment:
Drug: Oxytocin (OXT) continuous
24 IU of oxytocin every 3 days
Active Comparator group
Description:
24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days
Treatment:
Drug: Placebo
Drug: Oxytocin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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